Module 14 2022

22/03/2022

• Before & After Brexit • EU vs UK legislation • Transition period • UK MDR 2002 • Approved Bodies • Conformity Assessment

The Organisation for Professionals in Regulatory Affairs

3

Before & After Brexit

Manufacturer

Manufacturer

UK Responsible Person

Authorized Rep

Importer

Importer

End User

End User

Manufacturer

Manufacturer

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

4

2